MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT ISP M.R.I. IMPLANTABLE PORT; PORT, CATHETER, IMPLANTED

Model Number 4808560

Device Problems Melted (1385); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

Event Type  malfunction  

Event Description

Scrub technician opened powerport kit on back table and noticed that a luer lock syringe was in the kit (not the type of syringe she was expecting), and that it looked like it was half melted.She was able to obtain another syringe.When she went to flush the catheter prior to using it, she found that there was a slit in the side of the catheter, which was approximately one centimeter from the tip.A whole new kit was then obtained.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT
• Type of Device: PORT, CATHETER, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 8910110
• MDR Text Key: 154867496
• Report Number: 8910110
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4808560
• Device Catalogue Number: 4808560
• Device Lot Number: REDS1576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1